In a vibrant democracy such as ours, public opinion plays a critical role in driving political debate and policy decisions. But as decision makers have become increasingly focused on the constant taking of the public's pulse, some have started to question whether democracy would be better served if pollsters were to draw distinctions between "informed" and "uninformed" opinions.

We at the Center share this concern. A central focus of our mission is to understand what the general public thinks about the exciting but daunting new age of genetic medicine. But we are keenly aware that as we solicit public opinion, we ask individuals to comment on a topic that involves complicated technologies and a confusing array of social and ethical issues about which they may have had little opportunity to consider inane depth. If those queried have time to hear about and reflect on all sides of the debate, will their opinions enrich the policy making process?

We believe they will. So, to get a better perspective of how people from diverse backgrounds grapple with challenges presented by a technology that now drives a wide array of medical and personal decisions, the Center has embarked on an ambitious public engagement project that draws on the relatively new process of "deliberative democracy." "Deliberative democracy" has emerged from a rather simple but transformative notion: that individual participation in democratic processes is of far greater value if it is informed participation. This more evolved and intimate way of assessing opinions seeks to understand not only what people are thinking about a particular issue but how that thinking changes as they learn more about the topic and discuss its many facets with individuals from different backgrounds and perspectives.

Working with our partners at the Public Forum Institute, highly respected for its work on taking issues to the public, and Knowledge Networks, who helped pioneer a technique known as "Deliberative Polling®," the Center is engaging citizens both in person and online to consider the role of reproductive genetic technology in society.

The Center has taken its issues on the road and online, offering the public the opportunity to take part in deliberative democracy. The Center is hosting six Genetics Town Halls across the country this summer. In each of these cities - Fort Worth, Kalamazoo, Nashville, New York, Sacramento and Seattle - the public has the opportunity to take part in 'deliberative democracy' live and in person.

Approximately 100 participants in each city are being recruited from all walks of life to include a variety of viewpoints. At each Genetics Town Hall, the participants learn about genetic technology through presentations and interactive discussions. Equipped with wireless handheld devices that allow instant audience responses, the participants are polled about their opinions on various aspects of genetic testing. They then break off into smaller groups to exchange their views about and deliberate on what they learned from the presentations. The polling is then repeated to see how sentiments might have changed following discussion. Meanwhile, the Center has also recruited 200 people - reflecting a diversity of incomes, ages, and cultural backgrounds- to participate in a month-long interactive exchange of these issues online. Participants have the opportunity to learn from the experts, hear potentially conflicting viewpoints, and then share their own perspectives.

Neither the online nor the in-person meetings steer participants toward any particular conclusions. In fact, we are going to great lengths to provide objective analysis and facilitate discussions that probe all aspects of the issues at hand. We want to see the extent to which someone's thinking evolves when allowed to marinate, so to speak, in a bit of education and discussion.

As decision-makers grapple with the many policy matters related to genetics, they will want to know what the public knows, thinks, fears and hopes for the future of genetic medicine. We think our online consultations, six-city Town Halls, together with focus groups, interviews, and our recently completed survey of over 4,800 citizens will begin to provide decision-makers with a detailed view of the American public opinion. We also think these inputs will help to establish models for public involvement in a host of vexing science policy concerns.

To read the Town Hall report, visit: http://www.dnapolicy.org/images/reportpdfs/GeneticTownHall.pdf

Kathy Hudson, Ph.D. Director, Genetics and Public Policy Center

On July 22, Center director Kathy Hudson and three other witnesses testified before the House Employer-Employee Relations Subcommittee on the promises and implications of genetic testing for both workers and employers. The successful mapping of the human genome makes possible a wide array of genetic research and discovery, but also raises questions about who should have access to genetic information and what role it will play in healthcare treatment and research, health insurance coverage, and employment. The hearing was the first in the U.S. House of Representatives to consider genetic antidiscrimination legislation since The Genetic Nondiscrimination Act (S.1053) passed the Senate in October 2003, by a vote of 95-0. "With this unprecedented potential for discovery comes an equally weighty challenge for public policymakers. That is information that seems to indicate the possibility of illness, disease, or other disorders could be used unjustly against people and their families," said Subcommittee Chairman Sam Johnson (R-TX), whose panel has jurisdiction over both the employer-provided health insurance and employment aspects of the genetic non-discrimination issue. "Employment decisions should be based on an individual's qualifications and ability to perform a job, not on the basis of factors, genetic or otherwise, that have no bearing on job performance."

Hudson shared with the subcommittee results from the recently completed Center survey of 4,834 Americans that shows an overwhelming majority of Americans oppose employers and health insurance companies having access to genetic information. When asked the question "if a genetic test shows that a person has an increased risk for disease, does the employer have the right to know," 92% said "no". Similarly, 80% opposed health insurance companies having access to this information. Opposition to employer and health insurer access to genetic test results has grown since a similar survey was conducted by the Genetics and Public Policy Center in 2002.

"The need for protections grows with every new test developed and with every new patient who decides to forego or delay genetic testing because of discrimination concerns," said Hudson."

Due to the complex nature of this issue, it is vital that careful deliberation precede any further legislation," said Johnson. "We need to know and understand the effects of current law before … taking further steps, so we aren't surprised by any unintended consequences the potential new legislation might have."

Gingrich, Miller, Healy and Murray

The Center's report, "Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos" was released at a public forum entitled "Custom Kids? Genetic Testing of Embryos" held January 8 in Washington, DC.

The forum discussion confronted, among other things, the implications of "crafting" children from inception to "fit our hopes and dreams," the danger of making policy based on fears of a genetically engineered "seven-foot-nine" Olympic athlete, and how a society that may accept testing embryos to avoid certain conditions may react to its opposite application, of, say, a deaf or dwarf couple using the technology to produce a like child.
Gingrich, Miller, Healy and Murray

The report released by the Center provides a primer on the science and technology behind PGD, lays out the many challenges and concerns raised by the technology and offers a detailed set of policy options-while remaining neutral on any single course of action- for decision-makers to consider.

The highlight of the event was the free-flowing panel discussion of PGD that featured Newt Gingrich, the former House Speaker; John Podesta, who served as President Clinton's Chief of Staff; Bernadine Healy, a White House adviser who previously served as director of the National Institutes of Health; Amy Laura Hall, an Assistant Professor of Theological Ethics at Duke University; Paul Steven Miller, former commissioner with the Employment Equal Opportunity Commission and an executive branch adviser on genetics and health policy; Thomas Murray, president of The Hastings Center; and Joe Leigh Simpson, a geneticist who chairs the Department of Obstetrics and Gynecology at Baylor College of Medicine.

For plain text version of the report: www.dnapolicy.org/news.release.php?action=detail&pressrelease_id=24

To view the Forum Summary and video: www.dnapolicy.org/news.past.php?action=detail&past_event_id=20

Marketing genetic tests directly to the public has raised concerns among government advisory groups, geneticists, and public health advocates. Direct-to-consumer marketing, which includes both advertising and selling products or services directly to consumers, has raised concerns that consumers will obtain genetic tests of dubious value or without adequate explanation of their risks and limitations. As a result, consumers may make poor health care decisions.

The Center has completed a legal analysis of direct-to-consumer genetic test marketing, the first of its kind, which is scheduled for publication in the August 2004 volume of the Oklahoma Law Review. Center policy analyst Gail Javitt presented a talk on the subject at the annual meeting of the American Society of Bioethics and the Humanities in October 2003, and Center deputy director Joan Scott presented a poster on the topic at the annual meeting of the American College of Medical Genetics in March 2004. On June 15, 2004, Javitt testified before the Secretary's Advisory Committee on Genetics Health and Society concerning the Committee's Draft Resolution on Direct-to-Consumer Marketing of Genetic Tests.

Additionally, Center director Kathy Hudson moderated a session at a one-day workshop to discuss direct-to-consumer marketing on March 23 at the National Human Genome Research Institute

The Center participated in a panel session at the annual meeting of the Food and Drug Law Institute on April 16 in Washington, DC. The session, "Regulatory Issues in Pharmacogenetics and Pharmacogenomics," focused on how pharmacogenetic and pharmacogenomic research will influence drug development, as well as the role that the FDA can and should play in such developments.

Pharmacogenetics and pharmacogenomics focus on identifying human genetic variations that influence how well drugs work. Why different people react differently to medications has a genetic basis, but is poorly understood.

Panelists described therapeutic advances made possible through pharmacogenetic and pharmacogenomic research as well as expected future benefits of such research. They also discussed the industry's response to the FDA's 2003 draft guidance document on these of pharmacogenetic and pharmacogenomic data in drug development, the FDA's interest in and concerns about this research, and identified outstanding scientific and regulatory issues.

Policy analyst Gail Javitt moderated the session. The panelists at the session: Dr. Brian Spear, Director of Pharmacogenomics at Abbot Laboratories' Global Pharmaceutical Research and Development; Dr. Steven Shak, Chief Medical Officer and co-founder of Genomic Health, Inc.; Dr. Lawrence Lesko, Director of the Office of Clinical Pharmacology and Biopharmaceutics in the FDA's Center for Drug Evaluation and Research; Dr. Steven Gutman, Director of the Office of In Vitro Diagnostic Device Evaluation and Patient Safety in the FDA's Center for Devices and Radiological Health; Dr. Barbara Binzak, Associate with the law firm of Buchanan Ingersoll, and Center director Dr. Kathy Hudson.

In March, the Center and The Genetic Alliance co-sponsored a workshop in Washington, DC that brought together expert panelists and advocacy leaders to review current genomic discoveries and their impact on treating cancer.

The workshop covered topics that ranged from using new genetic discoveries in developing new cancer treatments to how emerging technologies may lead to genetic discrimination. The presentation charted out a path illustrating how new genetic information can lead to new medical products, how the biotechnology industry validates such products, and how clinicians pass along the benefits of these new products to patients.

Advocacy leaders were able to ask questions and work in small groups to discuss specific issues of greatest concern to their constituents. Each group outlined strategies for influencing future policy with a greater patient focus.

Speakers included: Dr. Francis Collins, Director of the National Human Genome Research Institute, Dr. Nicholas Dracopoli, Vice President of Clinical Discovery Technologies at Bristol-Myers Squibb, Dr. Janet Warrington, Vice President of Clinical and Applied Genomics Research and Development at Affymetrix, Dr. Dan Hayes, Clinical Director of the Breast Oncology Program at University of Michigan, Ms. Sharon Terry, President and CEO of Genetic Alliance, and Center director, Dr. Kathy Hudson. The workshop was also supported by Genomic Health.

An article by policy analyst Gail Javitt and Kathy Hudson entitled Regulating (for the Benefit of) Future Persons: A Different Perspective on the FDA's Jurisdiction to Regulate Reproductive Cloning, published in the December 2003 volume of the Utah Law Review. To read the article, visit the Center's website: http://www.dnapolicy.org/resources/RegulatingForBenefitOfFuturePersons.pdf

An issue brief on first trimester screening: The American College of Obstetricians and Gynecologists recently issued a new Committee Opinion on first-trimester prenatal screening methods for chromosome abnormalities, including nuchal fold translucency screening. To read more about first trimester screening and the policy issues surrounding it, visit the Center's website: http://www.dnapolicy.org/policy.issue.php?action=detail&issuebrief_id=39

Courts have been called upon to resolve a variety of disputes arising from reproductive genetics, from wrongful birth to unauthorized genetic testing in the workplace. As reproductive genetic technologies become more widespread, legal disputes may arise more frequently. To read more about the most relevant areas of the law and litigation that relate to reproductive genetics, visit the Center's website: http://www.dnapolicy.org/policy.repro.php

In March, the President's Council on Bioethics (PCB) released a new report entitled, "Reproduction and Responsibility: The regulation of New Biotechnologies."

The report covers aspects of biotechnology related to assisted reproduction and embryo research; it also includes recommendations for data collection, oversight and self-regulation by professional societies, and some limited legislative measures. Some of the specific recommendations made in the report are:

• Government-funded studies on the long-term health of babies born following invitro fertilization,
  
• Improvement in data reporting by fertility clinics about the uses, success rates, health effects and costs of in vitro fertilization and preimplantation genetic diagnosis,
  
• Federal prohibitions on certain procedures, such as transferring a human embryo into a non-human, or making a hybrid human-animal embryo.

Center director Kathy Hudson's commentary on the Presidential Bioethics Committee Report: "Reproduction & Responsibility: The Regulation of New Biotechnologies" will be published in the July/August issue of the Hastings Center Report.

Canadian lawmakers passed legislation establishing the Assisted Human Reproduction Agency of Canada (AHRAC). Charged to protect the health and safety of Canadians undergoing assisted reproduction treatments, the AHRAC will form a regulatory board to monitor clinics that perform in vitro fertilization and other fertility treatments. The Agency will also act as a warehouse for data collection.

The legislation prohibits creating human embryos solely for research purposes but allows research on unused human embryos created for fertility procedures. Reproductive cloning is also banned under the law, while limited embryonic stem cell research is permitted. Additionally, the new law bans payment to egg and sperm donors, and prevents women who act as surrogate mothers from accepting payments beyond compensation for illness or time-off from work.

The Human Fertilisation & Embryology Authority (HFEA) has relaxed the rules governing preimplantation genetic diagnosis (PGD) in order for families to have a child who would be a tissue match for a seriously ill sibling.

In 2001, the HFEA adopted a precautionary approach and decided that selecting for tissue match sibling could only be done in combination with selection against genetic diseases. Their concern was the potential risk of embryo damage from the procedure. Now, after three years of successful embryo biopsies both in the UK and abroad, the HFEA has carefully reviewed the safety of the technique and sees no evidence of increased risk.

The HFEA is a government body that regulates and inspects all UK clinics providing IVF, donor insemination, or the storage of eggs, sperm or embryos. The HFEA also licenses and monitors all human embryo research conducted in the UK.

The Center recently completed the largest survey ever of public attitudes toward genetic testing. This study, which involved 4,834 participants nationwide, covered more topics than the Center's previous survey conducted in 2002.

The current survey measures the public's awareness and approval of genetic technologies and views on the need for regulation of various reproductive genetic technologies.

Results of the survey are currently being analyzed and details results will be published this fall. See also 5/3/04 press release at www.dnapolicy.org.

The poster, entitled, "Prenatal care providers' practices regarding cystic fibrosis screening two years after ACOG guidelines: preliminary findings," was presented at the annual meeting of the National Coalition for Health Professional Education in Genetics, January 29-30 in Bethesda, Maryland. Authored by Teresa Doksum, Barbara Bernhardt, Lisa LeRoy, Center research analyst Andrea Kalfoglou, deputy director Joan Scott, and director Kathy Hudson, the poster summarized that many providers are not familiar with the specifics of the 2001 American College of Obstetrics and Gynecology (ACOG) guidelines, and implementation is inconsistent.

In 2001, the ACOG and the American College of Medical Genetics recommended that providers "offer" carrier testing for cystic fibrosis (CF) to all preconception and pregnant couples if at least one parent is Caucasian, and "make available" carrier testing to parents of other ethnic groups. These guidelines represent the first widespread offering of any prenatal genetic test to individuals without a family history.

The Center conducted telephone interviews with 20 U.S. prenatal care providers: 5family physicians, 5 obstetrician-gynecologists, 5 nurse midwives, and 5 prenatal genetic counselors. The interviewees were asked to describe their current practices of CF carrier screening as well as their views about how well the ACOG guidelines were being implemented in general. Only genetic counselors were consistently familiar with details of the ACOG guidelines.

Why, after two years, has CF carrier testing not become the standard? This study suggests that first, health care providers may be confused about the terminology in the guidelines, whether "offer" and "make available" mean the same thing. Second, some providers expressed doubts about the benefits of testing non-Caucasians at all. Third, insurance companies cover fetal testing, but not carrier testing of adults. And lastly, some providers cited that local professional guidelines differ from those issued by the ACOG.

In memory of Francis Crick, Nobel Prize Winner and co-discoverer of the double helical structure of DNA, who died July 28, 2004.